DRAP REGISTERED MEDICAL DEVICE
AmiCORE Apheresis Kit Single Needle with two platelet Containers [Disposable Apheresis Kit] P6R8882-AmiCORE Apheresis Kit. is registered with DRAP under number MDIR-0001211 as a Class C (moderate to high risk) medical device, imported. The listed holder is Fresenius Kabi Pakistan (Pvt) Ltd.. Its listed renewal date (19 Jan 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001211 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00266
| Device | AmiCORE Apheresis Kit Single Needle with two platelet Containers [Disposable Apheresis Kit] P6R8882-AmiCORE Apheresis Kit. |
|---|---|
| Class | C |
| Listed holder | Fresenius Kabi Pakistan (Pvt) Ltd. |
| Holder address | First Floor, Tanwir Ahmed MEdical Center (TAMC), MM Alam Road, 27-C/3, Gulberg III, Lahore |
| Manufacturing site | M/s. Fresenius Kabi AG 61346 Bad Homburg, Germany M/s. Fenwal International, Inc Carretera Sanchez Km 18. Parque Industrial Itabo, Zona Franca Ind. de S.c.,Haina, Dominican Republic |
| Issued | 20 Jan 2020 |
| Renewal date | 19 Jan 2025 |
| Licence | ELI-00266 |
Specifications
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Screened 5 Oct 2026, 21:31 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIR-0001210 | AmiCORE Apheresis Kit Single Needle [Disposable Apheresis Kit] P6R8880-AmiCORE Apheresis Kit | Class C |
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| MDIR-0001745 | Amicus Apheresis Kit-Single Needle with Platelet Additive solution Connector X6R2301 | Class C |
| MDIR-0001746 | Amicus Apheresis Kit-Double Needle with Platelet Additive solution Connector [X6R2302] | Class C |
| MDIR-0001814 | Agilia VP IN Reference :Z019597 | Class C |
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| MDIR-0001816 | Agilia VP MC IN Reference: Z019697 | Class C |
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| MDIR-0001818 | Agilia SP MC IN Reference: Z018697 | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0007404 | AmiCORE Apheresis kit-single needle with two platelet connectors and PAS connector (X7R8884) Apheresis Kit [X7R8884] | Class C | Uniplan Trade International Pvt ltd |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.